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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US

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THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US Back to Search Results
Model Number 102956
Device Problem Mechanical Problem (1384)
Patient Problem No Patient Involvement (2645)
Event Date 06/19/2014
Event Type  malfunction  
Manufacturer Narrative
No patient involvement.The device was returned for analysis.The complaint investigation determined the reported difficulty was the result of a design related wear issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.
 
Event Description
It was reported that the centrimag motor started making rattling noise of some sort.The pump was reseated, but the noise continued.The motor was placed on mock loop and with movement of power wire on motor the rattling noise was produced.This event was previously not reported due to no patient information.Abbott made the decision on (b)(6) 2018 to initiate a voluntary recall, therefore this event is being upgraded to reportable.
 
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Brand Name
CENTRIMAG MOTOR, US
Type of Device
CENTRIMAG MOTOR
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ  CH-8005
Manufacturer (Section G)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ   CH-8005
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key7775177
MDR Text Key116867890
Report Number2916596-2018-03352
Device Sequence Number1
Product Code DWA
UDI-Device Identifier07640135140078
UDI-Public07640135140078
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial
Report Date 08/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number102956
Device Catalogue Number102956
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/13/2018
Initial Date FDA Received08/11/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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